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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 212266


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NDA 212266 describes CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Amneal Pharms, Apozeal Pharms, Aurobindo Pharma, Bajaj, Chartwell Molecular, Chartwell Rx, Cypress Pharm, Hetero Labs Ltd Iii, Perrigo R And D, Pharm Assoc, Quagen, Ranbaxy Labs Ltd, Taro, Tris Pharma Inc, Jubilant Generics, Novel Labs Inc, Sandoz, and Sun Pharm, and is included in twenty NDAs. It is available from forty-six suppliers. Additional details are available on the CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY profile page.

The generic ingredient in CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and fifty-seven suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 212266
Pharmacology for NDA: 212266
Medical Subject Heading (MeSH) Categories for 212266
Suppliers and Packaging for NDA: 212266
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride SOLUTION;ORAL 212266 ANDA QUAGEN PHARMACEUTICALS LLC 70752-103 70752-103-06 1 BOTTLE, PLASTIC in 1 CARTON (70752-103-06) / 118 mL in 1 BOTTLE, PLASTIC
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride SOLUTION;ORAL 212266 ANDA QUAGEN PHARMACEUTICALS LLC 70752-104 70752-104-06 1 BOTTLE, PLASTIC in 1 CARTON (70752-104-06) / 118 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;ORALStrength5MG/5ML
Approval Date:May 16, 2019TE:RLD:No

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